Fallopian tube obturating device

ABSTRACT

A surgical device for obturating the fallopian tubes at the point of juncture with the walls of the uterus to effect temporary female sterilization. The device is positioned through the cervix using an endoscope and pneumatic insuflating means, and includes a removable plug member which permits normal ovulation.

[22] Filed:

United States Patent 1.19'1

Sinnreich 1 Nov. 11, 1975 [54] FALLOPIAN'TUBE OBTURATING DEVICE [76] Inventor: Manfred Sinnreich, 160 Fort Hill Road, Scarsdale, NY. 10583 Jan. 11, 1974 21 1 App1.,1 1o.: 432,700

52 us. c1. 128/1 R; 128/130 8/1969 Mozolf 128/1 R 3/1972 Keshin 3/1 3,648,683 3/1972 Brodie 1215/] R 3.675.639 7/1972 Cimber 128/130 3.805.767 4/1974 Erb 128/1 R Primary E. \'aminerDalton L. Truluck Attorney, Agent, or FirmTemko & Temko 57 ABSTRACT A surgical device for obturating the fallopian tubes at the point of juncture with the walls of the uterus to effect temporary female sterilization. The device ispositioned through the cervix using an endoscope and pneumatic insuflating means, and includes a removable plug member which permits normal ovulation.

4 Claims, 7 Drawing Figures US. Patent Nov.11,1975 Sheet10f2 3,918,431

FALLOPIAN TUBE OBTURATING DEVICE BACKGROUND OF THE INVENTION This invention relates generally to the field of'female sterilization, and more particularly to an improved device for obturating the fallopian tubes to prevent ovulation, as well as means and techniques for positioning and removal of such devices.

It is known in the art to effect permanent sterilization by cauterization performed through an endoscope, without the necessity of making an abdominal incision, and in cases where this procedure is not feasible or desirable, the tubes can be reached for cauterization through the abdomen by inserting a pneumoperitoneum-forming device.

The above procedures effect, with varying degrees of reliability, a permanent sterilization, and is normally resorted to in cases where other methods of birth control are not feasible. Aside from the factor of reliability, the performance of surgical procedures of the above type are not without risk, particularly where body cavities are pneumatically inflated using an inert gas. Aside from injury due to overinflation, numerous cases of the formation of embolisms have been reported.

Recently, liquid silicone has been used to block the oviducts of rabbits, successfully preventing pregnancy. Usifigthis technique, the silicone, as it solidifies, conforms precisely to the lumen of the oviduct. The success of such a technique withthe human female has yet to be established, and one obvious shortcoming is the lack of any means with such a plug for positive engagement within the tube, so that it will not be subsequently expelled. I I

BRIEF DESCRIPTION OF THE PRESENT INVENTION Briefly stated, the invention contemplates the provision of an obturating device which -is positioned through the uterus into the communicating lumen of the fallopian tube, using an endoscope and associated manipulating means The device includes a first element which remains relatively permanently in position at the end of the fallopian tube, and a removable plug element uncovering an opening establishing communication from the tube and permitting normal ovulation. The device is preferably formed of synthetic resinous materials which will not be incompatible with the installed situs, and include means for positive engagement at the situs, so as not to be expelled. The plug element may include a permanent magnet to improve tool engagement retention. One form of device includes a tapered member extending into the fallopian tube. Another form is of generally planar configuration,'and is attached to the uterine wall surrounding the lumen of the tube by integrally molded snelled hooks.

BRIEF DESCRIPTION OF THE DRAWINGS In the drawings, to which reference will be made in the specification, similar reference characters have been employed to designate corresponding parts throughout the several views.

FIG. I is a fragmentary longitudinal sectional view showing a first embodiment of the invention in installed condition, with a positioning tool engaged therewith.

FIG. 2 is a similar fragmentary sectional view showing the disengagement-of aplug element to permit normal ovulation.

FIG. 3 is a view in elevation showing a device upon the end of a positioning tool prior to installation.

FIG. 4'is an enlarged fragmentary view in elevation, partly in, section, showing the engagement oftool means-with tool receiving means on the plug element.

FIG. 5v is a transverse sectional view as seen from the plane 5-5 in FIG. 1.

FIG. 6 is a view in elevation showing a second embodiment of the invention.

FIG. 7 is a central sectional view of the second embodiment as seen from the plane-77 in FIG. 6.

DETAILED DESCRIPTION OF THE DISCLOSED EMBODIMENTS In accordance with the first embodiment of the invention, the device, generally indicated by reference character- 10, comprises broadly: a main body element 11 and a detachable plug element 12'.

As best seen in FIGS. 1 to 3, inclusive, the main body element ll is of generally tapered configuration, and includes a frusto-conically shaped member 15 having a first or outer end 16, and a second or inner end 17, and an axially disposed tapered bore 18, the outer end of which is threaded at 19. The outer end may be slightly flaired as at 20, to facilitate engagement of the plug element-l2, as will be more fully apparent hereinafter.

The outer surface 21 of the member 15 is provided with a plurality of arcuate projections 22 each having first and second surfaces 23 and 24, respectively, meeting in a relatively thin edge 25 which provide means for engaging the inner wall of the fallopian tube, generally indicated by reference character 29, to resist untended withdrawal. An annular flange 26 provides positioning means whereby the main body element 11 is prevented from being inserted to an excessive degree within the tube. At the outer end 16 of the member 15, there are provided first and second curvate recesses 27 and 28, respectively, for the selective engagement of a manipulating tool to be subsequently described.

The plug element 12, like the main body element I1 is preferably formed from a suitable synthetic resinous material, and includes a magnetized hard metallic insert 30 which serves as tool retention means, the insert being surrounded by a synthetic resinous sheath 31, the plug being preferably formed by insert molding operations well known in the molding art. The insert 30 is preferably tubular in configuration, and extends between first and second ends 32-33, and may include a knurled surface 34 to prevent shifting in position during the molding operation. The sheath 31 includes a distal end 36, a tapered cylindrical wall 37, the outer surface 38 of which is threaded, and a proximal end 39 defining an end surface 40 having toolengaging bores 41 extending thereinto. The bores '41 each include oppositely positioned inner recesses 42 which assist in tool retention.

To position the device in situ, employing an endoscope requires a manipulating tool 44 adapted to be inserted within the longitudinal bore of the endoscope (not shown). The tool 44 includes a first or outer element 45 and a concentrically disposed second or inner element 46. l

The outer element 45 comprises a hollow flexible tube 48 approximately 5mm in diameter having an outer manually 'engagable knurled member 49 which projects outwardly of the proximal end of the endoscope. The inner end 50 thereof mounts first and second prongs 5I-52 arranged in slightly converging relation to permit convenient engagement with the curvate recesses 27-28, as best seen in FIGS. I and 2. Proper seating is determined by the engagement of the terminals 53 with the outer surface of the flange 26.

The inner element 46 comprises a solid tube 56 of diameter sufficiently small to fit within the bore of the tube 48. An outer end 57 includes a manually engageable knurled member 58 which projects outwardly of the member 49. An inner end 61 mounts first and second prongs 62-63 which selectively engage the bores 41 as best seen in FIG. 4.

Insertion of the device within the fallopian tube commences with the positioning of the same with the plug element 12 in position on the end of the tool 44 as seen in FIG. 3. The entire assembly is then positioned within the bore of the endoscope (not shown) and the endoscope is inserted in well known manner within the uterus, following which the uterus is insuflated to expose the fallopian tubes. Upon loeation of the lumen of the tubes, the tool 44 is moved outwardly from the distal end of the endoscope, whereby the narrow end of the member 15 is inserted into the lumen to the position shown in FIG. 1 wherein the device 10 is fully seated. Next, keeping the inner element 46 engaged with the plug element 12, the outer element 45 is withdrawn, leaving the device in fully seated condition. Following this, the inner element 46 is disengaged, the amount of force necessary to effect such disengagement being insufficient to overcome the reactive force provided by the engagement of the arcuate projections 26 with the inner walls of the tube. The device may be left in this position as long as required, and may be removed in its :entirety by re-engaging the device as shown in FIG. 1, and exerting a combined rotational and retractive movement to both the outer element 45 and the inner element 46.

Should it be desired to permit normal ovulation, the plug element 12 can be separately removed as shown in FIG. 2 by first re-engaging the tool 44 as shown in FIG. 1, and while holding the outer element 45 stationary, the inner element 46 is rotated to threadedly disengage the plug element 12 from the main body element 11. Oncedisengaged, the plug element I2 may be backed offinto the tube 48 as shown in FIG. 2, the retentive effect of the prong 62-63 being assisted by the magnetic attraction of the insert 30. Normally, by the time this procedure is required, the device will have firmly seated itself within the fallopian tube, and the outer element 45 may be withdrawn without difficulty. Replacement of the plug as desired may be made at any time, the tapered configuration of both the plug element and the bore 18 facilitating the repositioning of the former.

Turning now to the second embodiment of the invention, illustrated in FIGS. 6 and 7, the device, generally indicated by reference character 68, differs from the first embodiment in the elimination of the frusto-conical portion of the main body element, and the substitution thereof of a planar main body element 69.

The element 69 includes an outer surface 70, and an inner surface 71 and is bounded by a generally circular peripheral edge 72. A threaded bore 73 extends through the plane of the element 69 to accommodate a plug element 74. Extending from the inner surface 71 are a plurality of snelled books 75 which are adapted to directly engage the inner surface of the uterine wall to be retained thereby. The plug element 74 is of relatively short axial length. and is provided with a domed inner surface 77 adopted to directly overlie the lumen of the tube to exert a sealing force thereagainst. Two engaging bores 78 and 79 correspond to those of the first embodiment, and the device is installed and removed as is the case in the first embodiment.

I wish it to be understood that I do not consider the invention limited to the precise details of structure shown and set forth in this specification, for obvious modifications will occur to those skilled in the art to which the invention pertains.

I claim:

I. A fallopian tube obturator for use in effecting permanent or reversible female sterilization by positioning the same to overlie the lumen of said fallopian tube, said obturator comprising: a main body element including a frusto-conically-shaped member of diameter permitting entry into a fallopian tube, and a radiallyextending flange forming a stop means located at a larger end thereof, said frusto-conical member including a tapered through bore, the larger end of which is threaded, said plug element being of correspondingly tapered configuration and having a mating threaded outer surface; whereby the tapered fit between said plug element and said frusto-conical member serves as a guide to facilitate engagement therebetween, and limit the extent of said engagement to a predetermined degree.

2. A fallopian tube obturator for use in effecting permanent or reversible female sterilization by positioning the same to overlie the opening to the lumen of said fallopian tube, said obturator comprising a main body element having means thereon for engaging tissue bordering said lumen, and defining a generally centrally positioned threaded opening overlying said opening to said lumen, a plug element having threaded means selectively engaged with said opening to close said lumen; said main body element having first tool-engaging means, said plug element including second tool-engaging means concentrically arranged with respect to said first tool-engaging means, whereby said obturator may be installed in position as a unit, and engagement of said first and second tool-engaging means permits the holding of said body element in installed position while disengaging said plug element therefrom.

3. Structure in accordance with claim 2, further characterized in said main body element being of a generally planar configuration and having an inner surface having hooked means extending therefrom for positive engagement with a portion of a uterine wall surrounding the lumen of a fallopian tube; said main body element defining a threaded centrally disposed opening, said plug element including a domed inner wall adapted to exert a sealing pressure against the opening to said lumen.

4. The method of effecting reversible female sterilization, comprising the steps of: providing a composite fallopian tube obturator including a main body element having means thereon for engaging tissue bordering said lumen and defining a generally centrally positioned threaded opening overlying the opening to said lumen, and a plug element having threaded means selectively engaged with said opening to close said lumen, said main body element having first tool-engaging means, said plug element having tool-engaging means; providing a composite manipulative tool including a hollow tube having first means engaging said first toolsaid plug element, as required. by engaging said first 6 means with said first tool-engaging means on said main body element to hold said main body element in installed position while cngaging said means on said shaft with said second tool-engaging means to disengage and remove said plug element with respect to said main body element. 

1. A fallopian tube obturator for use in effecting permanent or reversible female sterilization by positioning the same to overlie the lumen of said fallopian tube, said obturator comprising: a main body element including a frusto-conically-shaped member of diameter permitting entry into a fallopian tube, and a radially-extending flange forming a stop means located at a larger end thereof, said frusto-conical member including a tapered through bore, the larger end of which is threaded, said plug element being of correspondingly tapered configuration and having a mating threaded outer surface; whereby the tapered fit between said plug element and said frusto-conical member serves as a guide to facilitate engagement therebetween, and limit the extent of said engagement to a predetermined degree.
 2. A fallopian tube obturator for use in effecting permanent or reversible female sterilization by positioning the same to overlie the opening to the lumen of said fallopian tube, said obturator comprising a main body element having means thereon for engaging tissue bordering said lumen, and defining a generally centrally positioned threaded opening overlying said opening to said lumen, a plug element having threaded means selectively engaged with said opening to close said lumen; said main body element having first tool-engaging means, said plug element including second tool-engaging means concentrically arranged with respect to said first tool-engaging means, whereby said obturator may be installed in position as a unit, and engagement of said first and second tool-engaging means permits the holding of said body element in installed position while disengaging said plug element therefrom.
 3. Structure in accordance with claim 2, further characterized in said main body element being of a generally planar configuration and having an inner surface having hooked means extending therefrom for positive engagement with a portion of a uterine wall surrounding the lumen of a fallopian tube; said main body element defining a threaded centrally disposed opening, said plug element including a domed inner wall adapted to exert a sealing pressure against the opening to said lumen.
 4. The method of effecting reversible female sterilization, comprising the steps of: providing a composite fallopian tube obturator including a main body element having means thereon for engaging tissue bordering said lumen and defining a generally centrally positioned threaded opening overlying the opening to said lumen, and a plug element having threaded means selectively engaged with said opening to close said lumen, said main body element having first tool-engaging means, said plug element having tool-engaging means; providing a composite manipulative tool including a hollow tube having first means engaging said first tool-engaging means, and a shaft disposed within said hollow tube and rotatably and axially movable relative thereto, said shaft having means selectively engaging said second tool-engaging means; engaging said obturator, using said tool whereby said plug element engaged with said main body element overlies and closes the opening to the lumen of a fallopian tube, and removing said plug element, as required, by engaging said first means with said first tool-engaging means on said main body element to hold said main body element in installed position while engaging said means on said shaft with said second tool-engaging means to disengage and remove said plug element with respect to said main body element. 